U.S. EPA’s Pharmaceuticals Rule to be Kicked to Next Administration

According to the Healthcare Environmental Resource Center, “EPA will not be publishing a rule finalizing the Hazardous Waste Pharmaceuticals Rule in October of 2016 along with the Hazardous Waste Generator Improvements final rule and previously projected.”

Pharmacy retailers have anxiously awaited the finalManagement Standards for Hazardous Waste Pharmaceuticalsrule (80 Fed. Reg. 50,014), after the U.S. Environmental Protection Agency (U.S. EPA) published the proposed rule on September 25, 2015 in the Federal Register, but it appears the wait will continue. Pharmacy retailers have hoped that the final rule would, among other things, provide a means of avoiding Large Quantity Generator (LQG) status and the onerous requirements, which are ill-suited for retailers. However, based on discussions with U.S. EPA sources, we now understand that the Pharmaceuticalsrule is not likely to be finalized before the change in presidential administration. Given the change in administration, and depending on the election results, we may not see a final Pharmaceuticalsrule for years.

As background, LQG notifications at many pharmacy retail stores are driven solely by unused nicotine-replacement therapy (NRT) products (gum, lozenges, and patches), which must be disposed as hazardous waste once the item is expired, customer-returned, or otherwise unsalable. Because this waste stream must be managed as acute hazardous waste, the weight of the products can quickly push a retail store over the 2.2-pound LQG acute hazardous waste threshold. If the Pharmaceuticalsrule is finalized in its current form, the rule will likely eliminate the classification of LQGs for retailers, given that the weight of hazardous waste pharmaceuticals – which is broadly defined to include NRT – will not count toward a retailer’s generator status.

Even more troubling about the delay in thePharmaceuticalsrule is that the proposedHazardous Waste Generator Improvements Rule(80 Fed. Reg. 57,918), which was published in the Federal Register on the same day as thePharmaceuticalsrule, and which we understood U.S. EPA intended to keep on the same timing track as thePharmaceuticalsrule, was sent to OMB on June 10, 2016. We understand U.S. EPA intends to issue the final rule before the administration change. Should the Generator Improvements Rulebe finalized without thePharmaceuticals rule, pharmacy retailers would not be provided a regulatory mechanism to avoid LQG status that was likely under thePharmaceuticalsrule. When both rules appeared to be on the same track to being finalized, pharmacy retailers hoped to register pharmacy stores as CESQGs as a result of thePharmaceuticalsrule – because of managing pharmaceuticals under the proposed Subpart P, which would not count toward the store’s generator status. That approach would allow such pharmacy retailers to then avoid the need to comply with those newGenerator Improvements Rulerequirements applicable to only SQGs and LQGs. However, if the Generator Improvements Ruleis finalized and implemented without the Pharmaceuticalsrule, pharmacy retailers are likely to remain LQGs and must then modify certain hazardous waste program components to comply with theGenerator Improvementsrule. This would include, for example, more stringent labeling requirements and waste determination requirements. Although theGenerator ImprovementsRuledoes allow for “episodic generation” as requested by retailers, as proposed, the rule is not likely to provide the flexibility necessary for a pharmacy retailer to rely upon the provision to avoid registering as an LQG.

Once finalized, theGenerator Improvements Rulewould become effective on the rule’s effective date in Alaska and Iowa. In all other states, for those requirements in the rule that are more stringent than existing rules, such as the labeling and waste determination requirements, states must first revise their regulations to include the more stringent provisions. Although the more stringent requirements will not be effective in most states until states adopt the requirements, pharmacy retailers should, nonetheless, begin to consider whether hazardous waste management program revisions are likely to be warranted. Because theGenerator Improvements Ruleis broadly applicable to all hazardous waste generators, not simply retailers, generators in other industries should also begin assessing their programs.

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